Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-04-18 @ 4:17 PM
Study NCT ID:
NCT02475967
Status:
COMPLETED
Last Update Posted:
2018-02-27
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': '3 months', 'description': 'Health-related quality of life, assessed by HeartQol'}], 'secondaryOutcomes': [{'measure': 'Adherence to the E-learning packages', 'timeFrame': '3 months', 'description': 'Adherence to the E-learning packages as assessed by the number of logs and the cumulative log time on the E-learning platform per patient.'}, {'measure': 'Effectiveness of E-learning packages', 'timeFrame': '3 months', 'description': "Effectiveness of intervention in improving patients' knowledge of cardiac diseases as assessed by questionnaire scores."}, {'measure': 'User experience of eLearning platform', 'timeFrame': '3 months', 'description': 'Asses user experience of eLearning platform by User Experience Questionnaire (UEQ)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['E-Learning', 'coronary artery disease', 'telerehabilitation', 'e-health'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'In the trial cardiac patients will be provided with unrestricted access to the web-based eLearing platform for a one-month period.', 'detailedDescription': 'Patients participating in the trial will be provided with a cardiac web-based eLearning platform for one month during study period. The medical content of the packages will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists).\n\nE-Learning packages type I: videos with information from caregivers. In these videos, medics and paramedics are interviewed to highlight the etiology, pathophysiology and treatment of coronary artery disease; the associated comorbidities and the ways to prevent recurrence.\n\nE-Learning packages type II: videos in which patients are interviewed. Patients can help each other to adhere to their treatment plan, by sharing stories from their own experience about their illness and the rehabilitation afterwards. Short clips of maximum 2 minutes will be provided to study participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting\n\nExclusion Criteria:\n\n* Patients with dementia or cognitive impairment not being able to sufficiently understand the E-Learning packages content\n* (Foreign) patients unable to speak Dutch, thereby not being able to understand the content of the E-Learning packages\n* Patients with advanced visual and/or auditory impairments, hindering them to adequately understand the E-earning packages\n* Patients participating in another trial during the Pilot study period\n* Patients refusing to provide signed consent'}, 'identificationModule': {'nctId': 'NCT02475967', 'acronym': 'eEduHeart I', 'briefTitle': 'Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'eEduHeart I: a Multi-center Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-based eLearning Platform', 'orgStudyIdInfo': {'id': 'PDEN-IFRE 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.', 'interventionNames': ['Other: Intervention group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group patients receive conventional cardiac care alone.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Intervention group', 'type': 'OTHER', 'description': 'The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.The content of platform will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists). Patients will also contribute to platform content.', 'armGroupLabels': ['Intervention group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'The control group patients receive conventional cardiac care alone.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'ZOL', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Ines Frederix, drs.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hasselt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jessa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'prof. dr. Paul Dendale', 'investigatorAffiliation': 'Hasselt University'}}}}